Truth Runner: Another Top Ranked Mobile Game of CooTek

PR Newswire

SHANGHAI, Sept. 16, 2021 /PRNewswire/ — As a dark horse in the list of US IOS games — a week into its launch, Truth Runner has already risen to the top and is still charging ahead. This hyper-casual parkour game developed by Taptek, a game studio invested by CooTek (Cayman) Inc. (NYSE: CTK) (“CooTek” or the “Company”), has laid an excellent foundation for the Company’s upcoming game releases in the second half of the year.

Truth Runner is a creative parkour game targeting female users. Besides the parkour and dress-up elements inherited from CooTek’s previous hit, Catwalk Beauty, Truth Runner also allows players to choose their own parkour outfit based on the result of a personality test. A personality report is generated at the end of the game, which proves to be an appealing feature to numerous light game lovers of Generation Z.

In order to attract potential players, the game offers bright visual effects and personality/fortune tags in the personality test, which are designed to use memes in the popular culture. In the fortune-telling part, the creative team at Taptek has included many trending elements that are of interests to the Gen Z players, e.g., romantic relationship, weight, money, etc., making the game a trending topic on social networks. On YouTube, a large number of users have shared the screen recordings of their test results, which have also brought more traffic to the game.

For CooTek, mobile gaming is a crucial part of its recreational content roadmap. The Company’s experience and growth potential have enabled constant product incubations and iterations. The light, fast and mini-sized games developed by Cootek are widely popular among people with modern and fast-paced lifestyle. The in-depth and comprehensive strategy adopted by CooTek’s game business has also encouraged its invested games studios to create numerous hit games. As to the team behind Truth Runner, Taptek, its capabilities and resources in game design, localization, optimization and ROI have helped it accumulate creative ideas and explore the games best catered to the local users.

It has been the key objective of CooTek to create high-quality games with max user value. Taptek is still working on the game’s optimization and localization to launch in other overseas markets. It is believed that Truth Runner will keep its lead in the mobile gaming race.

About CooTek (Cayman) Inc.

CooTek is a mobile internet company with a global vision that offers content-rich mobile applications, focusing on three categories: online literature, scenario-based content apps and mobile games. CooTek’s mission is to empower everyone to enjoy relevant content seamlessly. CooTek’s user-centric and data-driven approach has enabled it to release appealing products to capture mobile internet users’ ever-evolving content needs and helps it rapidly attract targeted users.

For more information on CooTek, please visit https://ir.cootek.com.

For investor enquiries, please contact:

CooTek (Cayman) Inc.
Mr. Robert Yi Cui
Email: [email protected]

ICA Investor Relations (Asia) Limited
Mr. Kevin Yang
Phone: +86-21-8028-6033
E-mail: [email protected]

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SOURCE CooTek (Cayman) Inc.

Gogoro, a Technology Leader in Urban Electric Mobility and Battery Swapping, to List on Nasdaq Through a Merger With Poema Global Holdings Corp.

– Gogoro Inc. has entered into a definitive merger agreement with Poema Global Holdings Corp. that sets Gogoro’s enterprise value at $2.35 billion; upon closing, the combined company will list on the Nasdaq under the ticker symbol “GGR.”

– The business combination is expected to provide approximately $550 million in proceeds (assuming no redemptions) to Gogoro’s balance sheet including an oversubscribed PIPE of over $250 million as well as $345 million currently held in trust by Poema Global.

– The PIPE is funded by strategic partners including Hon Hai (Foxconn) Technology Group and GoTo Group, the largest technology group in Indonesia, vehicle partners, and new and existing financial investors including Generation Investment Management, Taiwan’s National Development Fund, Temasek as well as Gogoro’s founding investor, Dr. Samuel Yin of Ruentex Group.

– Use of proceeds include expansion into China, India and Southeast Asia as well as continued research and development of Gogoro’s leading battery swapping ecosystem and its smart, sustainable urban mobility solutions.

– The transaction closing is targeted for the first quarter of 2022.

PR Newswire

HONG KONG and TAIPEI, Taiwan, Sept. 16, 2021 /PRNewswire/ — Gogoro® Inc. (“Gogoro” or the “Company”), a global technology leader in battery swapping ecosystems that enable sustainable mobility solutions for cities, and Poema Global Holdings Corp. (Nasdaq: PPGH; “Poema Global”), a publicly traded special purpose acquisition company, today announced a definitive agreement for a business combination that would result in Gogoro becoming a publicly listed company. The combined company will focus on accelerating the global expansion of Gogoro’s unique and proven subscription-based battery swapping service along with its electric vehicle and component sales business. Upon the transaction closing, the combined company will be named Gogoro Inc. and will be listed on the Nasdaq under the ticker symbol “GGR.”

Gogoro’s battery swapping ecosystem is an established leading solution for electric refueling of lightweight urban vehicles. In less than five years, the Company has accumulated over $1 billion in revenue and 400,000+ battery swap subscribers.

“Gogoro is transforming urban mobility in the world’s most densely populated cities by changing how people use and share portable energy. Since launching in 2015, Gogoro battery swapping has handled more than 200 million battery swaps and saved over 300 million kilograms of CO2. Building off of this success, we have announced our expansion into China with Yadea and DCJ, and into India with Hero MotoCorp,” said Horace Luke, founder, chairman, and chief executive officer of Gogoro. “Much of today’s world commutes on two wheels, and cities are embracing sustainable energy and smart city technologies in unprecedented ways. One of the greatest challenges is transitioning from legacy personal transportation systems to more intelligent and sustainable mobility solutions. With our vision, innovative technology, expanding global footprint and experienced management team, Gogoro is well positioned to transform the urban mobility landscape and capitalize on the electric transition of more than a half billion two-wheel vehicles.”

As part of its growth strategy, Gogoro will be introducing its battery swapping in China in late 2021, and is partnering with Yadea, the #1 electric two-wheel maker in the world, and Dachangjiang Group (DCJ), the #1 gas-powered two-wheel maker in China. The Company has also announced a joint venture with Hero MotoCorp, the leading two-wheel vehicle maker in India, to build its battery swapping ecosystem in India. In addition, Gogoro has established partnerships with other global leaders in two-wheel mobility, including Yamaha, Tailing eReady (a joint venture with Suzuki in Taiwan), AeonMotor, PGO and CMC eMOVING.

“Poema Global is excited to be partnering with Gogoro, a global technology leader in urban electric mobility that has demonstrated the scalability and attractiveness of its next generation battery swapping technology in Taiwan,” said Homer Sun, chief executive officer of Poema Global. “We believe the technology differentiation Gogoro has developed in combination with the world-class partnerships it has forged will drive significant growth opportunities in the two largest two-wheeler markets in the world. We are committed to working alongside Gogoro’s outstanding management team to support its geographic expansion plans and its transition to a Nasdaq-listed company.”  

Gogoro – A Leader in Urban Mobility

Founded in 2011, Gogoro has designed and built a broad portfolio of innovations in battery swapping, smart batteries, cloud services, compact electric propulsion, and vehicle design. Together, these innovations have created an enablement platform for companies to deliver new urban mobility products and businesses utilizing the largest and most intelligent urban mobility ecosystem focused on battery swapping for electric refueling.

The Gogoro Network is an open platform for battery swapping and smart mobility services, delivering a fresh alternative to legacy fuel. Gogoro Network combines the power of smart connectivity, artificial intelligence, and machine learning to create a new generation of swappable battery refueling that is smart, scalable, and continually optimizing itself to be dynamic and versatile for people, communities, and businesses. Gogoro has been recognized by Guidehouse Insights as the leading battery swapping company for lightweight urban vehicles in the world.

First introduced in 2015, Gogoro’s Smartscooters™ are recognized for their revolutionary design and performance and lead the market in sophistication, intelligence, and consumer reviews.

Partners, Investors and Leadership

Gogoro’s current portfolio of vehicle maker partners include Hero MotoCorp, Yadea, Dachangjiang (DCJ), Yamaha, Tailing eReady (a joint venture with Suzuki in Taiwan), AeonMotor, PGO and CMC eMOVING. These partners are part of the Powered By Gogoro Network (PBGN) program, a cornerstone of Gogoro’s open ecosystem. The PBGN program enables partners to design and sell vehicles that integrate with Gogoro Network battery swapping.

Gogoro is backed by world-class investors, including Dr. Samuel Yin, Founder and Chairman of Ruentex Group; Temasek, a global investment company headquartered in Singapore; Generation Investment Management, a sustainable investment company; Fuh Hwa Investment Trust, a large private equity fund in Taiwan; Sumitomo Corporation, a Japanese conglomerate; and the National Development Fund of Taiwan.

Prior to founding Gogoro, Horace Luke held a variety of management positions at Microsoft, including being a founding member of the XBox leadership team before serving as the chief innovation officer at HTC, where he led HTC to the #1 position in the global smartphone market and the leader in Android. Gogoro’s leadership team members are seasoned executives from global brands including Amazon, Intel, Nike, IKEA and Ford. In addition, Gogoro has an industry-leading board with directors such as Michael Splinter, current chairman of Nasdaq and former CEO of Applied Materials, and Yoshi Yamada, a former senior executive at Panasonic and later Head of Tesla’s Giga Factory.

Transaction Overview

The Gogoro Poema Global business combination sets Gogoro’s enterprise value at $2.35 billion. The business combination is expected to provide approximately $550 million in proceeds to Gogoro’s balance sheet including an oversubscribed PIPE over $250 million and $345 million currently held in trust by Poema Global. The PIPE is backed by strategic partners including Hon Hai (Foxconn) Technology Group and GoTo Group, the largest technology group in Indonesia, vehicle partners, and new and existing financial investors including Generation Investment Management, Taiwan’s National Development Fund, Temasek and founding investor, Dr. Samuel Yin of Ruentex Group. Current Gogoro shareholders are rolling 100% of their equity and will hold majority ownership of the combined company at closing. Cash proceeds raised in connection with the transaction will primarily be used to fund geographic expansion and operations, continued research and development, and for general corporate purposes.

The boards of directors of both Poema Global and Gogoro have approved the proposed transaction. Completion of the proposed transaction is subject to the approval of Poema Global and Gogoro shareholders and other customary closing conditions, including a registration statement being declared effective by the U.S. Securities and Exchange Commission (the “SEC”). The transaction is expected to be completed in the first quarter of 2022.

Additional information about the proposed transaction, including a copy of the business combination agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by Poema Global with the SEC and available at www.sec.gov.

Advisors

Kirkland & Ellis LLP is serving as legal advisor to Poema Global. Citibank and UBS are serving as joint placement agents on the PIPE offering. Winston & Strawn LLP is serving as legal advisor to the placement agents. Wilson Sonsini Goodrich & Rosati is serving as legal advisor and Goldman Sachs is serving as financial advisor to Gogoro.

Investor Conference Call Information

Gogoro and Poema Global will host a joint investor conference call to discuss the proposed transaction today, September 16, 2021 at 8:30 am ET. To listen to the prepared remarks via webcast, please visit http://public.viavid.com/index.php?id=146462. A replay of the call will be available at the same link as well as on Poema Global’s website at https://www.poema-global.com/ through September 30, 2021 at 11:59 pm ET.

About Poema Global Holdings Corp.

Poema Global Holdings Corp. is a special purpose acquisition company affiliated with Princeville Capital formed for the purpose of entering into a combination with one or more businesses. Poema Global’s sponsor team brings together over 100 years of combined experience to equip and enable a differentiated global technology leader to successfully list and to create long-term value for shareholders in public markets. Led by Co-Chairmen Emmanuel DeSousa and Joaquin Rodriguez Torres, Chief Executive Officer Homer Sun and President Marc Chan, Poema Global seeks to complete business combinations with companies that have validated technologies and attractive unit economics, with a particular focus on Asia and Europe. For more information, visit https://www.poema-global.com/.

About Gogoro

Founded in 2011 to rethink urban energy and inspire the world to move through cities in smarter and more sustainable ways, Gogoro leverages the power of innovation to change the way urban energy is distributed and consumed. Gogoro’s battery swapping and vehicle platforms offer a smart, proven and sustainable long-term ecosystem for delivering a new approach to urban mobility. Gogoro has quickly become an innovation leader in vehicle design and electric propulsion, smart battery design, battery swapping, and advanced cloud services that utilize artificial intelligence to manage battery availability and safety. The challenge is massive, but the opportunity to disrupt the status quo, establish new standards, and achieve new levels of sustainable transportation growth in densely populated cities is even greater. For more information, visit www.gogoro.com/news and follow Gogoro on Twitter: @wearegogoro.

Forward Looking Statements

This communication contains forward-looking statements within the meaning of section 27A of the U.S. Securities Act of 1933, as amended, or the Securities Act, and section 21E of the U.S. Securities Exchange Act of 1934 (“Exchange Act”) that are based on beliefs and assumptions and on information currently available to Poema Global and Gogoro. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including projections of market opportunity and market share, the capability of Gogoro’s technology, Gogoro’s business plans including its plans to expand globally, its timing for introducing its battery swapping in China, the sources and uses of cash from the proposed transaction, the anticipated enterprise value of the combined company following the consummation of the proposed transaction, any benefits of Gogoro’s partnerships, strategies or plans as they relate to the proposed transaction, anticipated benefits of the proposed transaction and expectations related to the terms and timing of the proposed transaction are also forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Although each of Poema Global and Gogoro believes that it has a reasonable basis for each forward-looking statement contained in this communication, each of Poema Global and Gogoro caution you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. In addition, there will be risks and uncertainties described in the proxy statement/prospectus on Form F-4 relating to the proposed transaction, which is expected to be filed by Gogoro with the SEC and other documents filed by Gogoro or Poema Global from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Neither Poema Global nor Gogoro can assure you that the forward-looking statements in this communication will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, the ability to complete the business combination due to the failure to obtain approval from Poema Global’s shareholders or satisfy other closing conditions in the business combination agreement, the occurrence of any event that could give rise to the termination of the business combination agreement, the ability to recognize the anticipated benefits of the business combination, the amount of redemption requests made by Poema Global’s public shareholders, costs related to the transaction, the impact of the global COVID-19 pandemic, the risk that the transaction disrupts current plans and operations as a result of the announcement and consummation of the transaction, the outcome of any potential litigation, government or regulatory proceedings and other risks and uncertainties, including those to be included under the heading “Risk Factors” in the registration statement on Form F-4 to be filed by Gogoro with the SEC and those included under the heading “Risk Factors” in the annual report on Form 10-K for year ended December 31, 2020 of Poema Global and in its subsequent quarterly reports on Form 10-Q and other filings with the SEC. There may be additional risks that neither Poema Global or Gogoro presently know or that Poema Global and Gogoro currently believe are immaterial that could also cause actual results to differ from those contained in the forward looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by Poema Global, Gogoro, their respective directors, officers or employees or any other person that Poema Global and Gogoro will achieve their objectives and plans in any specified time frame, or at all. The forward-looking statements in this communication represent the views of Poema Global and Gogoro as of the date of this communication. Subsequent events and developments may cause those views to change. However, while Poema Global and Gogoro may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of Poema Global or Gogoro as of any date subsequent to the date of this communication.

Important Additional Information Regarding the Transaction Will Be Filed With the SEC

In connection with the proposed transaction, Gogoro will file a registration statement on Form F-4 with the SEC that will include a prospectus with respect to Gogoro’s securities to be issued in connection with the proposed transaction and a proxy statement with respect to the shareholder meeting of Poema Global to vote on the proposed transaction. Shareholders of Poema Global and other interested persons are encouraged to read, when available, the preliminary proxy statement/prospectus as well as other documents to be filed with the SEC because these documents will contain important information about Poema Global, Gogoro and the proposed transaction. After the registration statement is declared effective, the definitive proxy statement/prospectus to be included in the registration statement will be mailed to shareholders of Poema Global as of a record date to be established for voting on the proposed transaction. Once available, shareholders of Poema Global will also be able to obtain a copy of the F-4, including the proxy statement/prospectus, and other documents filed with the SEC without charge, by directing a request to: 101 Natoma St., 2F, San Francisco, CA 94105. The preliminary and definitive proxy statement/prospectus to be included in the registration statement, once available, can also be obtained, without charge, at the SEC’s website (www.sec.gov).

Participants in the Solicitation

The Company and Gogoro and their respective directors and executive officers may be considered participants in the solicitation of proxies with respect to the potential transaction described in this communication under the rules of the SEC. Information about the directors and executive officers of Poema Global and their ownership is set forth in Poema Global’s filings with the SEC, including its Form 10-K for the year ended December 31, 2020 and subsequent filings under section 16 of the Exchange Act or on Form 10-Q. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Poema Global’s shareholders in connection with the potential transaction will be set forth in the registration statement containing the preliminary proxy statement/prospectus when those are filed with the SEC. These documents are available free of charge at the SEC’s website at www.sec.gov or by directing a request to: 101 Natoma St., 2F, San Francisco, CA 94105.

No Offer or Solicitation

This communication is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and does not constitute an offer to sell or a solicitation of an offer to buy any securities of Company or Gogoro, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.

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SOURCE Gogoro

Chindata Group Participates in China’s First Green Power Transaction

BEIJING, Sept. 16, 2021 (GLOBE NEWSWIRE) — Chindata Group (Nasdaq: CD), a leading carrier-neutral hyperscale data center solution provider in Asia-Pacific emerging markets, today announced that it has recently participated in China’s first nationwide green power transaction, and completed a procurement of 100 million kilowatt-hours (kWh). Such volume represents around 1.26% of the overall transaction and is expected to directly reduce greenhouse gas emissions by approximately 94,000 tons of carbon dioxide equivalent. According to public data, a total of 259 domestic Chinese entities participated in this green power transaction, with a total transaction volume of 7.935 billion kWh.

Following the announcement of China’s goals of reaching peak carbon emissions by 2030 and carbon neutrality by 2060, a series of policies were introduced, with the pilot schemes for national carbon emissions trading and national green power trading being one of them. Such has offered additional alternatives to the green energy consumption ecosystem and make available more opportunities for Chindata Group as a digital infrastructure company.

Chindata Group has been constantly exploring and has identified four major initiatives for the strategic development of its green power consumption ecosystem and will continue to implement strategic upgrades. These initiatives include direct green power trading, innovative regional green power consumption mechanisms, development of renewable energy power stations and development of integrated power Generation-Grid-Load-Storage projects. Together these are expected to set examples for the paths of green electricity consumption for digital infrastructure companies in China, while also further strengthening the sustainability initiatives of Chindata Group.

For the exploration on the innovative regional green power consumption mechanisms, Chindata Group has made accessibility to green energy one of its core site selection principles for its hyperscale data center infrastructure clusters. Zhangjiakou city in Hebei Province is China’s first National Renewable Energy Demonstration Zone, and has been the home base for Chindata Group’s first hyperscale data center cluster in the pan-Beijing area. Chindata Group has consumed a total of 440.2 million kWh green power through the green power consumption mechanisms in this region and reduced green gas emissions of around 415,000 tons.

In addition, Chindata Group is continuing to strengthen the uptake of green power and development of power plants. According to its 2020 ESG report, renewable energy accounted for 51% of annual total power consumption of its data centers. With abundant local renewable resources as a leverage, Chindata Group also seek to develop renewable energy power plants to provide consistent green electricity for its digital infrastructure. Its 150MW smart photovoltaic power plant oriented for local electricity consumption is expected to produce approximately 200 million kWh annually upon completion, directly cutting around 212,000 tons of carbon dioxide equivalent every year.

Meanwhile, Chindata Group is also exploring the development of power Generation-Grid-Load-Storage integration projects so as to promote the deep integration of new generation power systems with digital businesses, and has proposed the idea of China’s first super energy complex. To date, Chindata Group has reached renewable energy development agreement with several local governments.  

With robust demand from businesses, coupled with favorable government policies, Chindata Group is well-positioned to further align itself with the global effort in achieving net zero carbon emissions. It will continue to deliver high-quality solutions to digital leaders and be their company along their course of carbon reduction.

About Chindata Group

Chindata Group (NASDAQ: CD) is a leading carrier-neutral hyperscale data center solution provider in Asia-Pacific emerging markets and a first mover in building next-generation hyperscale data centers in China, India and Southeast Asia markets, focusing on the whole life cycle of facility planning, investment, design, construction and operation of ecosystem infrastructure in the IT industry. Chindata Group provides its clients with business solutions in major countries and regions in Asia-Pacific emerging markets, including asset-heavy ecosystem chain services such as industrial bases, data centers, network and IT value-added services.

Chindata Group operates two sub-brands: “Chindata” and “Bridge Data Centres”. Chindata operates hyper-density IT cluster infrastructure in the Greater Beijing Area, the Yangtze River Delta Area and the Greater Bay Area, the three key economic areas in China, and has become the engine of the regional digital economies. Bridge Data Centres, with its top international development and operation talents in the industry, owns fast deployable data center clusters in Malaysia and India, and seeks business opportunities in other Asia-Pacific emerging markets. Visit official website for more information: https://www.chindatagroup.com



For media enquiries, please contact:

Ms. Xiaolin Zhao
[email protected]

MISTRAS Group to Hold a Live Q&A Fireside Chat at the Sidoti Virtual Investor Conference

PRINCETON JUNCTION, N.J., Sept. 16, 2021 (GLOBE NEWSWIRE) — MISTRAS Group, Inc. (MG: NYSE) – a leading “one source” global provider of technology-enabled asset protection solutions used to maximize the uptime and safety of critical energy, industrial, and public infrastructure – announced today that Dennis Bertolotti, Chief Executive Officer, and Edward Prajzner, Chief Financial Officer, will participate in investor meetings and a fireside chat at the Sidoti Virtual Investor Conference.

The live presentation in a Question & Answer format will be on September 23, 2021, beginning at 9:15 AM Eastern. You may access this discussion at: https://sidoti.zoom.us/webinar/register/WN_InPLq397TWumFYFQU7PAKA

One-on-one meetings will be scheduled for September 22nd and 23rd. Investors interested in meeting with management should contact their Sidoti & Company representative to reserve a time.

About MISTRAS Group, Inc. – One Source for Asset Protection Solutions®

MISTRAS Group, Inc. (NYSE: MG) is a leading “one source” multinational provider of integrated technology-enabled asset protection solutions, helping to maximize the safety and operational uptime for civilization’s most critical industrial and civil assets.

Backed by an innovative, data-driven asset protection portfolio, proprietary technologies, and decades-long legacy of industry leadership, MISTRAS leads clients in the oil and gas, aerospace and defense, renewable and nonrenewable power, civil infrastructure, and manufacturing industries towards achieving and maintaining operational excellence. By supporting these organizations that help fuel our vehicles and power our society; inspecting components that are trusted for commercial, defense, and space craft; and building real-time monitoring equipment to enable safe travel across bridges, MISTRAS helps the world at large.

MISTRAS enhances value for its clients by integrating asset protection throughout supply chains and centralizing integrity data through a suite of Industrial IoT-connected digital software and monitoring solutions. The company’s core capabilities also include non-destructive testing field and in-line inspections enhanced by advanced robotics, laboratory quality control and assurance testing, sensing technologies and NDT equipment, asset and mechanical integrity engineering services, and light mechanical maintenance and access services.

For more information, please visit the company’s website at www.mistrasgroup.com or contact Nestor S. Makarigakis, Group Vice President of Marketing and Communications at [email protected].

Forward-Looking and Cautionary Statements

Certain statements made in this press release are “forward-looking statements” about MISTRAS’ financial results and estimates, products and services, business model, strategy, growth opportunities, profitability and competitive position, and other matters. These forward-looking statements generally use words such as “future,” “possible,” “potential,” “targeted,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “project,” “will,” “may,” “should,” “could,” “would” and other similar words and phrases. Such statements are not guarantees of future performance or results, and will not necessarily be accurate indications of the times at, or by which, such performance or results will be achieved, if at all. These statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. A list, description and discussion of these and other risks and uncertainties can be found in the “Risk Factors” section of the Company’s 2020 Annual Report on Form 10-K dated March 16, 2021, as updated by our reports on Form 10-Q and Form 8-K. The forward-looking statements are made as of the date hereof, and MISTRAS undertakes no obligation to update such statements as a result of new information, future events or otherwise.

Contact:

Nestor S. Makarigakis
Group Vice President, Marketing and Communications
MISTRAS Group, Inc.
[email protected]
+1 (609) 716-4000



LUMAKRAS™ (Sotorasib) Combined With Vectibix® (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer

New Data at ESMO 2021 Support Initiation of Phase 3 Trial of LUMAKRAS Plus Vectibix in Patients With 3L+ Colorectal Cancer

Amgen is Leading the Largest and Most Comprehensive Development Program in Patients with the KRAS G12C Mutation

PR Newswire

THOUSAND OAKS, Calif., Sept. 16, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the first combination study results from the Phase 1b/2 CodeBreaK 101 study, the most comprehensive global clinical development program in patients with KRAS G12C-mutated advanced colorectal cancer (CRC). These new data show that combining LUMAKRAS™ (sotorasib) with Vectibix® (panitumumab), Amgen’s monoclonal antibody epidermal growth factor receptor (EGFR) inhibitor, demonstrated encouraging efficacy and safety. Overall, the objective response rate (ORR) was 27% (confirmed and unconfirmed) among 26 patients in the efficacy analysis set (which included 5 patients who had progressed with prior sotorasib monotherapy). The disease control rate (DCR) was 81%. ORR and DCR were secondary endpoints. In the expansion cohort of sotorasib-naïve patients with refractory CRC (n=18), 33% of patients experienced a response (confirmed and unconfirmed). These data are being featured during the European Society of Medical Oncology 2021 (ESMO21) Virtual Congress.

“We are excited by these CodeBreaK 101 data, which show encouraging response rates that were much higher than the 9.7% response rate observed with LUMAKRAS monotherapy and highlight the importance of combination therapy for patients with KRAS G12C-mutated advanced colorectal cancer,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Based on these results and the urgent need for new therapies, we are pleased to announce the initiation of a new Phase 3 trial with LUMAKRAS plus Vectibix in the third-line setting. This new trial, along with our doublet and triplet combination trials in colorectal cancer, demonstrates our commitment to delivering a new treatment option for metastatic CRC patients who harbor the KRAS G12C mutation.”

In total, 31 patients with heavily pretreated (median of two prior lines of therapy; range 1-10) KRAS G12C-mutated metastatic CRC were enrolled in the dose exploration and dose expansion cohorts for the combination of LUMAKRAS and Vectibix. No patients experienced dose-limiting toxicities during the 28 days following initial treatment. The majority of treatment-related adverse events (TRAEs) were Grade 1-2 in severity, and no Grade 4 or fatal TRAEs were observed. The most common TRAEs (occurring in > 10% of patients) were consistent with known adverse events for LUMAKRAS and Vectibix and included dermatitis acneiform, dry skin, nausea, diarrhea, hypokalemia, hypomagnesemia, pruritus and rash. No new safety concerns were identified.

“With treatment response rates being as low as 2% in patients with colorectal cancer who progress in advanced stages, developing new treatment approaches for these patients is of critical interest,” said Marwan G. Fakih, M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, Calif. “Preclinical research has indicated that the addition of an EGFR inhibitor to KRASG12C inhibition can be synergistic, and now we have the first clinical data indicating the combination of sotorasib and panitumumab has the potential to be a safe and effective treatment for patients with KRAS G12C-mutated advanced CRC.”

Advancing Tarlatamab (formerly AMG 757) and AMG 404 in Small Cell Lung Cancer
In addition to the LUMAKRAS combination research, a presentation will detail the design of an ongoing study of half-life extended (HLE) bispecific T cell engager (BiTE®) molecule tarlatamab with anti-PD-1 antibody AMG 404 in patients with small cell lung cancer. The multicenter, open-label, Phase 1b study will evaluate the safety and tolerability of the combination and determine dosing as primary objectives, as well as examine preliminary antitumor activity and pharmacokinetics as secondary objectives.

Amgen to Webcast Investor Call at ESMO 2021
Amgen will host a webcast call for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2021 Congress. On Thursday, Sept. 16, 2021, at 8:30 a.m. ET,  David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with other members of Amgen’s management team, will discuss clinical data being presented on the Company’s KRASG12C inhibitor LUMAKRAS™ (sotorasib) in combination with Vectibix® (panitumumab).

Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. 

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.   

About LUMAKRASTM (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C inhibitor.1 LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.2

In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. LUMAKRAS is also approved in the United Arab Emirates, and in Great Britain and Canada under Project Orbis.

Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, LUMAKRAS has treated almost 3,000 patients around the world through the clinical development program and commercial use.

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen is participating in the FDA’s Project Orbis initiative and through the initiative, has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia and Brazil. Additionally, Amgen has submitted an MAA in the European Union, Japan, Switzerland, South Korea, Singapore, Israel, Turkey, Taiwan, Colombia, Thailand, Mexico and Hong Kong.

LUMAKRAS is also being studied in multiple other solid tumors.1

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRASG12C inhibitor clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication. 

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).

For information, please visit www.hcp.codebreaktrials.com.

About Advanced Colorectal Cancer and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 10% of all cancer diagnoses.3 It is also the third most commonly diagnosed cancer globally.4

Patients with previously treated metastatic CRC need more effective treatment options, as standard therapies yield median PFS times of about two months and patients’ response rates are less than 2%. 5,6

KRAS mutations are among the most common genetic alterations in colorectal cancers, with the KRAS G12C mutation present in approximately 3-5% of colorectal cancers.7,8,9

About BiTE® Technology
BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing BiTE molecules across a broad range of hematologic malignancies and solid tumors and further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

LUMAKRASTM (sotorasib) U.S. Indication
LUMAKRASTM is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

LUMAKRAS™ (sotorasib) Important Safety Information

Hepatotoxicity

  • LUMAKRAS™ can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
  • Among 357 patients who received LUMAKRAS™ in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS™ had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
  • Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS™, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
  • Withhold, dose reduce or permanently discontinue LUMAKRAS™ based on severity of adverse reaction.

Interstitial Lung Disease (ILD)/Pneumonitis

  • LUMAKRAS™ can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS™ in CodeBreaK 100, ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS™ was discontinued due to ILD/pneumonitis in 0.6% of patients.
  • Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS™ in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS™ if no other potential causes of ILD/pneumonitis are identified.

Most Common Adverse Reactions

  • The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.

Drug Interactions

  • Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
  • Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS™.
  • If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS™ 4 hours before or 10 hours after a locally acting antacid.

Please see LUMAKRASTM full Prescribing Information

About Vectibix® (panitumumab)

Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.

In June 2017, the FDA approved a refined indication for Vectibix for use in in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this usemCRC.

INDICATION AND LIMITATION OF USE 

Vectibix® is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): as first-line therapy in combination with FOLFOX, and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Limitation of Use: Vectibix® is not indicated for the treatment of patients with RAS mutant mCRC or for whom RAS mutation status is unknown.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: DERMATOLOGIC TOXICITY


Dermatologic Toxicity:

 Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix monotherapy 
[see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

  • In Study 20020408, dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients with mCRC receiving Vectibix®. The clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
  • Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix®. Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix®. It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune- related effects (e.g., Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix® concerning dermatologic toxicity are provided in the product labeling.
  • Vectibix® is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as “RAS.
  • Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS-mutant mCRC tumors received Vectibix® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysisOS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS-mutant mCRC who received Vectibix® and FOLFOX versus FOLFOX alone.
  • Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred in up to 7% (in Study 20080763) of patients across clinical trials. Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix® treatment, periodically during Vectibix® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
  • In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
  • Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix® in combination with chemotherapy.
  • Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix®. Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix®. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix® therapy. Discontinue Vectibix® therapy if ILD is confirmed.
  • In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix® versus the risk of pulmonary complications must be carefully considered.
  • Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix®.
  • Keratitis and serious cases of keratitis, ulcerative keratitis, known risk factors for and corneal perforation, have occurrred with Vectibix use. Monitor for evidence of keratitis , ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
  • In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at a higher rate in Vectibix®-treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs < 1%), and hypomagnesemia (4% vs 0).
  • NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in Vectibix®-treated patients (7% vs 3%) and included fatal events in three (< 1%) Vectibix®-treated patients. As a result of the toxicities experienced, patients randomized to Vectibix®, bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
  • Vectibix® can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix®.
  • In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
  • The most commonly reported adverse reactions (≥ 20%) with Vectibix® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. The most common serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.

To see the Vectibix® Prescribing Information, including Boxed Warning visit www.vectibix.com.

About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That’s why we’re relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we’re advancing oncology at the speed of life™.

For more information, follow us on www.twitter.com/amgenoncology.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)


References:

  1. Hong DS, et al. N Engl J Med. 2020;383:1207-1217.
  2. Skoulidis F, Li BT, Dy GK, et al. N Engl J Med. 2021;384(25):2371-2381. doi:10.1056/NEJMoa2103695.
  3. Rawla, P., Sunkara, T., & Barsouk, A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Gastroenterology Review, 2019: 14(2), 89-103.
  4. World Health Organization. 2020 Statistics. Accessed at: https://www.who.int/en/news-room/fact-sheets/detail/cancer on August 26, 2021.
  5. Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909-1919. doi:10.1056/NEJMoa1414325.
  6. Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303-312. doi:10.1016/S0140-6736(12)61900-X.
  7. Neumann J, Zeindl-Eberhart E, Kirchner T, Jung A. Frequency and type of KRAS mutations in routine diagnostic analysis of metastatic colorectal cancer. Pathol Res Pract. 2009;205(12):858-862. doi:10.1016/j.prp.2009.07.010.
  8. Jones RP, Sutton PA, Evans JP, et al. Specific mutations in KRAS codon 12 are associated with worse overall survival in patients with advanced and recurrent colorectal cancer. Br J Cancer. 2017;116(7):923-929. doi:10.1038/bjc.2017.37.
  9. Wiesweg M, Kasper S, Worm K, et al. Impact of RAS mutation subtype on clinical outcome-a cross-entity comparison of patients with advanced non-small cell lung cancer and colorectal cancer. Oncogene. 2019;38(16):2953-2966. doi:10.1038/s41388-018-0634-0.

 

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SOURCE Amgen

FinVolution Group Announces Inclusion in FTSE Russell Indexes

PR Newswire

SHANGHAI, Sept. 16, 2021 /PRNewswire/ — FinVolution Group (“FinVolution,” or the “Company”) (NYSE: FINV), a leading fintech platform in China, today announced that it will be added to the FTSE Global Equity Index Series (“GEIS”), including the FTSE Global All Cap Index and FTSE Global Small Cap Index, effective after the close of business on Friday, September 17, 2021.

“The inclusion of FinVolution in the FTSE Russell indexes marks another milestone in our successful equity story and continues to enhance our investment appeal and visibility among global investors,” Mr. Feng Zhang, the Chief Executive Officer of FinVolution, commented. “The inclusion is also a testament to the Company’s growth story and our leading position in the FinTech sector. With our relentless commitment to cutting-edge technologies, sophisticated credit risk management framework and strong execution capabilities, we are well-positioned to deliver long-term value to all shareholders through the next phase of our expansion.”

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide, calculating thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell indexes are used extensively by institutional and retail investors globally. Being part of this widely tracked index is expected to increase the attractiveness of FinVolution’s shares to potential international investors and further diversify the Company’s overall investor base.

About FinVolution Group

FinVolution Group is a leading fintech platform in China and internationally connecting underserved borrowers with financial institutions. Established in 2007, the Company is a pioneer in China’s online consumer finance industry and has developed innovative technologies and has accumulated in-depth experience in the core areas of credit risk assessment, fraud detection, big data and artificial intelligence. The Company’s platform, empowered by proprietary cutting-edge technologies, features a highly automated loan transaction process, which enables a superior user experience. As of June 30, 2021, the Company had over 130.8 million cumulative registered users.

For more information, please visit: http://ir.finvgroup.com.

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Such statements are based upon management’s current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. Potential risks and uncertainties include, but are not limited to, uncertainties as to the Company’s ability to attract and retain borrowers and investors on its marketplace, its ability to increase volume of loans facilitated through the Company’s marketplace, its ability to introduce new loan products and platform enhancements, its ability to compete effectively, laws, regulations and governmental policies relating to the online consumer finance industry in China, general economic conditions in China, and the Company’s ability to meet the standards necessary to maintain listing of its ADSs on the NYSE, including its ability to cure any non-compliance with the NYSE’s continued listing criteria. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of this press release, and FinVolution does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

For investor and media inquiries, please contact:

In China:
FinVolution Group
Head of Investor Relations
Jimmy Tan
Tel: +86 (21) 8030 3200 Ext. 8601
Email: [email protected]

The Piacente Group, Inc.
Jenny Cai
Tel: +86 (10) 6508-0677
Email: [email protected]

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SOURCE FinVolution Group

ATRenew Addresses Sustainable Development of Pre-owned Consumer Electronics Industry at 2021 CITIC CLSA Flagship Investors’ Forum

PR Newswire

SHANGHAI, Sept. 16, 2021 /PRNewswire/ — AiHuiShou International Co. Ltd. (“ATRenew” or the “Company”) (NYSE: RERE), a leading technology-driven pre-owned consumer electronics transactions and services platform in China, presented on the sustainable development of the pre-owned consumer electronics industry during the “Sustainable Society” themed webinar at the 28th Annual CITIC CLSA Flagship Investors’ Forum in 2021 (the “Event”). Kerry Xuefeng Chen, Founder, Chairman, and Chief Executive Officer attended the Event on behalf of the Company as its keynote speaker.

Kerry first talked about the growth potential and development of the pre-owned electronics market. The rapid development of information digitization, disposable income, and the mobile Internet in China have greatly shortened the iteration and replacement cycle of smart consumer electronic products. According to China Insight Consultancy statistics, there were more than 2.6 billion consumer electronic devices with use value circulating in China as of 2020. The majority of these devices were left unused or discarded, despite the fact that the disposal of electronic devices leads to tremendous waste and carbon emissions. Furthermore, when consumer electronic devices are discarded inappropriately, heavy metals from these devices can cause serious environmental harm. Therefore, the best solution is to identify and resell the electronic products that still have use value, so as to effectively alleviate the pressures of electronics disposal by extending the lifecycle of electronic products.

Discussing his vision for the sustainable development of the pre-owned consumer electronics market, Kerry expressed that through 10 years of hard work, ATRenew has integrated C2B, B2B, and B2C capabilities to cover the entire pre-owned consumer electronics value chain. Through the Company’s independent research and development of quality inspection, grading, and pricing technologies, ATRenew has integrated Internet and environmental protections to develop a business model and establish an enterprise supporting the development of the circular economy. The Company actively applies this business model to raise consumer awareness of recycling, enhance the transaction efficiency for pre-owned consumer products, prolong product lifecycles, set new industry standards, and promote industry development.

Based on the GRI standards of the Global Sustainability Standards Board (GSSB), industry standards of the Sustainability Accounting Standards Board Foundation (SASB), and ATRenew’s careful study of the relevant topics from MSCI, the world’s leading rating agency, and Sustainalytics, ATRenew draws on the experience of world leaders in ESG accountability to take the lead among public companies participating in the circular economy and release an annual ESG report. The Company took the lead in transparently disclosing all systems and measures designed for protecting user privacy and data security, standardizing the pre-owned electronics industrial chain, measuring the carbon emissions of all related parties in the industry chain in 2020, as well as ensuring the rights, safety, and welfare of its employees. ATRenew goes further to clarify each of the three critical issues in its ESG efforts. For environmental issues, the Company emphasizes energy conservation, emission reduction, and recycling, formulating clear supplier evaluation standards for the upstream and downstream supply chains, especially as relating to green transportation and environmentally friendly disposal. Socially, the Company emphasizes industry self-discipline, development of a transparent external communication mechanism, and the healthy development of employees, as well as comprehensive employee training, promotion mechanisms, and welfare. When addressing social responsibility, the Company has carried out digital education assistance programs for rural children and donated goods to areas that have been impacted by COVID-19 and are in need. In terms of corporate governance, the Company improved its top-level governance, established an ESG Committee, and enhanced corporate governance through effective risk and information security management mechanisms.

ATRenew is committed to and fully confident in promoting the sustainable development of the pre-owned consumer electronics industry. Riding the rapid pace of development, ATRenew has established a sense of sustainable development and embedded an environmental, social, and governance (“ESG”) framework into its very core. The Company continues to enhance its competitive advantages, business stability, and sustainability. The Company further strengthens its collaborations with supply chain participants and opens itself up to stakeholder supervision and broader communication channels. Environmentally, ATRenew will leverage its recycling expertise to build on its specialization strengths and fuel expansion, supplementing its quantitative plan to provide social benefits and bring its corporate governance to the next level.

On August 17, 2021, the Company published its first ESG report, highlighting the Company’s long-term initiatives focused on improving its environmental impact and furthering its social contributions in 2020. To view the report in full, please visit the ESG section of ATRenew’s Investor Relations website at ir.aihuishou.com or request a copy via email at [email protected]. Both English and Simplified Chinese versions are available.

About AiHuiShou
International Co. Ltd.

Headquartered in Shanghai, AiHuiShou International Co. Ltd. (“ATRenew”) (NYSE: RERE) operates a leading technology-driven pre-owned consumer electronics transactions and services platform in China under the brand ATRenew, which stands for “All Things Renew.” Since its inception in 2011, ATRenew has been on a mission to give a second life to all idle goods, addressing the environmental impact of pre-owned consumer electronics by facilitating recycling and trade-in services and distributing the devices to prolong their lifecycle. ATRenew’s open platform integrates C2B, B2B, and B2C capabilities to empower its online and offline services. Through its end-to-end coverage of the entire value chain and its proprietary inspection, grading, and pricing technologies, ATRenew sets the standard for China’s pre-owned consumer electronics industry.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to” and similar statements. Among other things, quotations in this announcement, contain forward-looking statements. ATRenew may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about ATRenew’s beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: ATRenew’s strategies; ATRenew’s future business development, financial condition and results of operations; ATRenew’s ability to maintain its relationship with major strategic investors; its ability to provide facilitate pre-owned consumer electronics transactions and provide relevant services; its ability to maintain and enhance the recognition and reputation of its brand; general economic and business conditions globally and in China and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in ATRenew’s filings with the SEC. All information provided in this press release is as of the date of this press release, and ATRenew does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Investor Relations Contact

In China:
AiHuiShou International Co. Ltd.
Investor Relations
Email: [email protected]

In the United States:
ICR, LLC
Email: [email protected]
Tel: +1-212-537-0461

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SOURCE AiHuiShou International Co. Ltd.

COVID Credit Crunch: 59% of UK Consumers Have Used Credit Cards ‘To Make Ends Meet’ During Pandemic

COVID Credit Crunch: 59% of UK Consumers Have Used Credit Cards ‘To Make Ends Meet’ During Pandemic

70% of consumers prefer Buy Now Pay Later (BNPL) to credit cards due to affordability and ease of management, with 54% saying BNPL will replace their use of credit cards

LONDON–(BUSINESS WIRE)–Marqeta (NASDAQ: MQ), the global modern card issuing platform, has today released a new report highlighting how the economic stress of the pandemic has increased the popularity of credit cards and flexible payment options – such as Buy Now Pay Later (BNPL). The survey of 1,000 UK consumers showed that nearly 3-in-5 (59%) respondents have relied on credit to make ends meet during the pandemic. Yet it also suggests that credit cards could soon be usurped by BNPL as the consumer credit option of choice. Seven out of 10 consumers reported that they prefer BNPL options to credit cards, citing affordability and ease of management as key reasons, while over half (54%) said that BNPL will replace their use of credit cards. This is despite 35% saying they had tried BNPL for the first time during the pandemic.

Worryingly, the survey showed that while having a wider range of credit options has provided essential support during the crisis, some have found themselves falling behind with payments and building up debt:

  • Of those consumers who were already using BNPL solutions before the pandemic, more than two-thirds (67%) reported that their use had increased over the last 12 months. However, more than half (53%) worry that it’s easier to fall into debt with BNPL compared with credit cards.
  • While 70% of consumers are more conscious of their credit card balance post-COVID, and 60% are more aware of budgeting, almost a quarter (23%) of consumers reported having struggled to keep up with minimum monthly card payments during the pandemic.
  • Despite this, 64% of consumers report using credit cards at least once per week and usage is frequent – with over two-fifths (42%) using their credit cards to make five or more purchases a week.

“Credit cards and BNPL have provided a lifeline for many during the pandemic,” says Ian Johnson, SVP, Managing Director, Europe, Marqeta. “The boom in online shopping due to global lockdowns – combined with the ongoing financial insecurity for millions of households – has created a perfect storm for the surge in BNPL and credit card use. Lots of people are living hand to mouth due to the financial strain of COVID and having flexible payment options has helped them to make ends meet – for example, by allowing them to purchase essentials when they need them, while paying for them at a time that suits.”

The shift towards non-traditional payment options has shown that consumers are increasingly looking for new experiences and innovation in payments. The report found that many consumers expressed interest in different types of credit cards, such as a card that supports environmental causes (72%), or a family credit card (43%). Others were keen for more variety in rewards, with lottery rewards and stock portions being popular options. 64% of those surveyed were interested in non-traditional rewards, with 82% interested in building their own rewards programme.

It also found that nearly three quarters (71%) of consumers think that credit history should be built on more than just credit card use – with 68% stating that they would be interested in a product that builds credit history, but is paid off immediately, like a debit card.

“COVID has irreversibly changed the payments industry. Consumers want to be in control of how they pay, with greater transparency, convenience, and the ability to monitor spending driving the shift towards non-traditional payment options,” concludes Johnson. “Offering new, user-friendly payments experiences has long been a battleground for banks. But the ongoing economic fallout of the pandemic means that customers are now looking for innovative payment options that give them true control over their finances. If banks don’t respond to shifting customer demand, they risk being left behind by their more forward-thinking competitors.”

State of Credit Report

To download the Marqeta 2021 State of Credit Report, please visit: https://www.marqeta.com/uk/resources/2021-state-of-credit

About Marqeta

Marqeta is the global modern card issuing platform empowering builders to bring the most innovative products to the world. Marqeta provides developers advanced infrastructure and tools for building highly configurable payment cards. With its open APIs, the Marqeta platform is used by leading European fintechs like Capital on Tap, Lydia and Twisto, who want to easily build tailored payment solutions to create best-in-class experiences and power new modes of money movement. Marqeta is headquartered in Oakland, California, is enabled in 36 countries globally and has offices in London, United Kingdom and Melbourne, Australia. For more information, visit www.marqeta.com, Twitter and LinkedIn.

Robert Fretwell

Spark Communications

[email protected]

KEYWORDS: North America United States Ireland United Kingdom Europe California

INDUSTRY KEYWORDS: Software Technology Professional Services Finance

MEDIA:

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Opera GX integrates CORSAIR iCUE to give a splash of color to gamers’ browsing

The world’s first browser designed for gamers ups its game by integrating CORSAIR iCUE to make CORSAIR RGB-enabled setups dynamically respond to browsing. Opening a tab, receiving a message or downloading a file has never looked better.

PR Newswire

OSLO, Norway, Sept. 16, 2021 /PRNewswire/ — Opera GX is introducing iCUE integration that makes CORSAIR gear dynamically respond to browsing. From now on, whenever you start the browser, open a new tab, finish a file download or complete any number of other browsing tasks, your CORSAIR gear will respond with one of a set of custom effects courtesy of Opera GX’s design team – further ensuring that Opera GX is an essential tool for every gamer

 

Let’s face it: you need to maintain your focus when gaming so you might want to take it easy with your RGB effects. As a browser, Opera GX is the perfect place for you to really let loose and make your setup shine through colors and animations,” said Maciej Kocemba, Head of Opera GX.

Launched in 2019 during E3 in Los Angeles, Opera GX is the world’s first browser designed for gamers and with the things they like in mind.

We are excited to help enhance the Opera GX browsing experience even further with iCUE support,” said Lauren Premo, Director of Gaming Marketing at CORSAIR. “It’s amazing to see what’s possible with the iCUE ecosystem when paired with creative partners like Opera.

Let your CORSAIR gear match the colors of your gaming and browsing

Opera GX is all about bringing the immersive gaming experience to browsing. It’s the first browser with a dynamic soundtrack and sound effects. It was also the first browser to include native Discord and Twitch support. Now, with the inclusion of CORSAIR iCUE software, GX is going to illuminate all your CORSAIR gear, from your memory to your mouse, with custom animations whenever you start the browser, open new tabs, finish a file download or activate the RAM, CPU and network limiters.

Gamers can choose from one of multiple preset animation themes or go deeper and individually choose one of the additional effects. They can also import any gif and use it for a specific thing they do in the browser, with just one click.

Opera GX will also display a gif on your CORSAIR keyboard whenever you get a notification from Discord, Twitch, Telegram, Facebook Messenger, Twitter, WhatsApp or Instagram.

iCUE effects are not displayed continuously, but rather when something occurs in the browser. In order to avoid distractions from late night gaming or binge-watching sessions, they can be dimmed in fullscreen mode.

Opera GX gamers can start enjoying iCUE features now with the browsers latest update. Gamers who haven’t yet taken control of their online browsing experience can join the action by downloading it from the Opera GX home page and joining the many million strong community of active users.

Opera GX

Since its inception in 2019, Opera GX has quickly become the browser of choice for millions of gamers seeking a more custom internet experience. Along with countless customization options including color themes, sound effects, background music, and a gaming-inspired design, GX includes CPU, RAM and Network Bandwidth limiters that make the browser less resource-hungry and leave more of the computer’s resources for gaming. The browser also includes a Hot Tabs Killer feature, which lets users “kill” the most resource-draining tabs and GX Cleaner to purge those old unwanted files. Opera GX launched its own Discord server which now has almost 350k members.

About Opera
Opera is a global web innovator. Opera’s browsers, news products and fintech solutions are the trusted choice of hundreds of millions people worldwide. Opera is headquartered in Oslo, Norway and listed on the NASDAQ stock exchange (OPRA).

About CORSAIR
CORSAIR (NASDAQ: CRSR) is a leading global developer and manufacturer of high-performance gear and technology for gamers, content creators, and PC enthusiasts. From award-winning PC components and peripherals, to premium streaming equipment and smart ambient lighting, CORSAIR delivers a full ecosystem of products that work together to enable everyone, from casual gamers to committed professionals, to perform at their very best.

CORSAIR also includes subsidiary brands Elgato, which provides premium studio equipment and accessories for content creators, SCUF Gaming, which builds custom-designed controllers for competitive gamers, and ORIGIN PC, a builder of custom gaming and workstation desktop PCs and laptops.

Copyright © 2021 Corsair Memory, Inc. All rights reserved. CORSAIR, the sails logo, and Vengeance are registered trademarks of CORSAIR in the United States and/or other countries. All other company and/or product names may be trade names, trademarks, and/or registered trademarks of the respective owners with which they are associated. Features, pricing, availability, and specifications are subject to change without notice.

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SOURCE Opera Limited

Silverback Therapeutics Presents Interim Clinical Results from the Ongoing Phase 1/1b Study of SBT6050 Alone or In Combination with Pembrolizumab in Patients with Advanced or Metastatic HER2-Expressing Solid Tumors

Silverback Therapeutics Presents Interim Clinical Results from the Ongoing Phase 1/1b Study of SBT6050 Alone or In Combination with Pembrolizumab in Patients with Advanced or Metastatic HER2-Expressing Solid Tumors

– Proof-of-mechanism established with activation of myeloid and T/NK cells, and evidence of SBT6050 payload localization in the tumor microenvironment –

– SBT6050 demonstrated a manageable safety profile with adverse events consistent with on-mechanism immune activation, both as a monotherapy or in combination with pembrolizumab –

– Early signals of anti-tumor activity observed in a heavily pre-treated, heterogeneous population –

– Management to host conference call today at 6:30 AM ET –

SEATTLE–(BUSINESS WIRE)–
Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today presented interim clinical results from a Phase 1/1b clinical study of SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors, at the 2021 European Society for Medical Oncology Congress.

“Over this past year, we have gathered compelling data with clear signals of SBT6050’s pharmacological activity, marked by the activation of both the innate and adaptive immune response in patients,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens.”

As of August 1, 2021, 40 patients with advanced or metastatic HER2-expressing or amplified solid tumors were enrolled into the SBT6050-101 trial. SBT6050 dose levels ranged from 0.3 to 1.2 mg/kg in the monotherapy dose escalation arm (Part 1), and 0.15 and 0.3 mg/kg in the pembrolizumab combination arm (Part 3). Patients received between 1 and 17 doses of SBT6050.

As a monotherapy and in combination with pembrolizumab, SBT6050 was generally well-tolerated, with an adverse event profile that is consistent with immune system activation and considered on-mechanism. “The adverse event profile thus far has been very manageable and importantly, suggests the potential to combine with other standard of care agents,” said Samuel Klempner, MD, Medical Oncologist at the Massachusetts General Hospital. “The signals of anti-tumor activity are encouraging and its complementary mechanism of action with standard-of-care agents makes SBT6050 attractive for combination regimens.”

Initial Safety Data

  • The most frequent treatment-related adverse events were consistent with immune activation, and included injection site reactions, fever and chills, hypotension, nausea, vomiting, and fatigue. These were mostly Grade 1 or 2 in nature, and no Grade 4 or higher related adverse events were reported.
  • At higher dose levels, dose limiting toxicities (DLTs) were observed and included Grade 3 hypotension, injection site reaction, fever, and hypoxia. These DLTs resolved with supportive care.
  • Cytokine release syndrome (CRS) > Grade 2 was not observed at any dose level.

Pharmacokinetic and Pharmacodynamic Data

  • SBT6050 exposures increased with dose and exhibited a linear PK profile at 0.6 mg/kg and higher. Linear exposure is evidence of saturation of receptor mediated clearance.
  • Conjugate stability was assessed using a highly sensitive assay, and no active levels of SBT6050’s free payload were detected in the blood and any amount of free payload was absent in 98% of all blood samples tested.
  • SBT6050 induces pharmacologic activity indicative of myeloid and NK/T cell activation at all dose levels, with effects plateauing at 0.6 mg/kg.
  • Pharmacodynamic activity is maintained with repeat dosing of SBT6050.

Anti-Tumor Activity

  • Early signals of anti-tumor activity were observed in a heavily pre-treated, heterogeneous population.
  • Among 18 evaluable patients for tumor types of interest, one patient with HER2 IHC 2+ NSCLC had a confirmed partial response (-55% per RECIST 1.1 criteria), maintained at the most recently available scan obtained at 36 weeks post-enrollment, and 8 weeks after discontinuing study treatment. In addition, stable disease was reported in seven patients.

SBT6050 targets the pertuzumab binding domain of HER2 and is designed to be used in combination with standard of care agents, including trastuzumab-containing regimens. Silverback will be discussing details of its expanded clinical development strategy on the scheduled investor webcast today.

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call today at 6:30 AM ET. A live webcast, including slides, can be accessed through the Events section of the Company’s website at https://ir.silverbacktx.com/news-events/events. An archived replay will be available shortly after the conclusion of the event.

About SBT6050

SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-containing therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

About Silverback Therapeutics

Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback’s plans and ability to bring new treatments to patients in need, including potential combination efforts, and the progress and expected timing of Silverback’s drug development programs and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Miguel Arcinas

Silverback Therapeutics

(206) 736-7946

[email protected]

Media Contact:

Jason Spark

Canale Communications

(619) 849-6005

[email protected]

KEYWORDS: United States North America Washington

INDUSTRY KEYWORDS: Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology

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